A Phase I/II Study Evaluating the Safety, Tolerability and Preliminary Efficacy of GLS-012 Monotherapy and in Combination With GLS-010 in Patients With Advanced Solid Tumors After Progression on Standard Treatment (Triumph-01)

Guangzhou Gloria Biosciences Co., Ltd.1 site in 1 country107 target enrollmentOctober 31, 2022

ConditionsSolid Tumor

InterventionsGLS-012 GLS-010

Overview

Phase: Phase 1
Intervention: GLS-012
Conditions: Solid Tumor
Sponsor: Guangzhou Gloria Biosciences Co., Ltd.
Enrollment: 107
Locations: 1
Primary Endpoint: Number of Participants with a Dose-Limiting Toxicity (DLT) and MTD in the dose escalation stage
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a phase I/II study to investigate the safety, tolerability, and preliminary efficacy of GLS-012 monotherapy and in combination with GLS-010 in subjects with advanced solid rumor after progression on standard treatment.

Registry

clinicaltrials.gov

Start Date

October 31, 2022

End Date

December 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Guangzhou Gloria Biosciences Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who are willing to sign the informed consent form;
•Aged 18-75 years, male or female;
•Histologically confirmed diagnosis of a solid tumor;
•Patients with advanced solid tumors after progression on standard treatment;
•Subjects must have at least 1 measurable target lesion according to RECIST version 1.1；
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1；
•Life expectancy more than 12 weeks;
•Adequate organ function and bone marrow function as indicated by the screening assessments in the screening period;
•Women of childbearing potential must use highly effective contraception during the study period and at least 6 months after the last study drug administration, and must have a negative blood pregnancy test within 3 days before study enrollment.

Exclusion Criteria

•Patients with irAEs of grade ≥ 3 in the previous immunotherapy, and the AEs of the last anti-tumor treatment have not recovered to grade ≤ 1, except for hypothyroidism/hyperthyroidism and dermatitis that have recovered to grade ≤ 2, and AEs with no safety risks judged by the investigators, for example, alopecia.
•Patients with primary or secondary immunodeficiency, or patients who are receiving long-term systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before randomization.
•Use of corticosteroids or other immunosuppressants for systemic treatment within 14 days before the first study drug administration;
•Known central nervous system (CNS) metastases;
•Patients with severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies in the past.
•Patients with other malignant tumors within 5 years before screening, except cured cervical carcinoma in situ and cured skin basal cell carcinoma.
•Cardiac clinical symptoms or diseases that are not well controlled.
•Known hereditary or acquired bleeding and thrombosis tendency.
•Patients with congenital or acquired immunodeficiency disorders (such as HIV-infection), or a history of organ transplantation.
•Patients complying with any of hepatitis B surface antigen (HBsAg) positive and HBV-DNA copies being more than 2500 copies/ml (or 500 IU/ml); or positive HCV-RNA;

Arms & Interventions

Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010

Intervention: GLS-012

Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010

Intervention: GLS-010

Outcomes

Primary Outcomes

Number of Participants with a Dose-Limiting Toxicity (DLT) and MTD in the dose escalation stage

Time Frame: Up to 21 days after the first dose

Number of participants with treatment-related adverse events of GLS-012 monotherapy and in combination with GLS-010 in the expansion stage as assessed by CTCAE V5.0

Time Frame: Up to approximately 24 months

Secondary Outcomes

Objective response rate (ORR)(Up to approximately 24 months)
Disease control rate (DCR)(Up to approximately 24 months)
Preliminary anti-tumor activity: Duration of response (DOR), time to response (TTR), progression free survival (PFS), overall survival (OS)(Up to approximately 24 months)
Maximum plasma concentration (Cmax) of GLS-012 monotherapy and in combination with GLS-010(Up to approximately 4.5 months)
Elimination half-life (T1/2) of GLS-012 monotherapy and in combination with GLS-010(Up to approximately 4.5 months)
Overall survival (OS)(Up to approximately 24 months)
Time to response (TTR)(Up to approximately 24 months)
Duration of response (DOR)(Up to approximately 24 months)
Progression free survival (PFS)(Up to approximately 24 months)